MannKind Corpâ€™s Afrezza Won Recommendations from U.S. Advisory Panel
After long-waiting for the approval of inhaled diabetes treatment drug, Afrezza, MannKind Corp. finally got recommendation from U. S. advisory panel. The panel of Food and Drug Administration (FDA) advisers has voted 13 in favor of recommending the drug for treating Type 1 and Type 2 diabetes.
Earlier, two times rejection of the MannKind's inhaled diabetes drug in 2011 and the release of Pfizer Inc's inhaled diabetes drug, Exubera, in 2006, caused the company to witness steep decrease in its shares from 21.70 to $1.60. But, the Pfizer Inc's Exubera later on faced setback as the drug showed increased risk of lung cancer because the insulin was directly deposited in the lungs.
Despite of recommendation from advisory panel, FDA raised the same concern claiming the Afrezza may cause lung function. Moreover, they added that the drug contains some missing information from the study conducted on Type 1 patients.
Alfred Mann, 88-year-old founder, chairman, chief executive officer and largest shareholder of the Company, said his company feels pleased on the approval recommendation of the Afrezza.
Diabetes is a major health problem in the U. S. and the development of the novel drug would prove successful in treating patients without following insulin injections, said Alfred.
According to statistical report by the Centers for Disease Control and Prevention (CDC), about 26 million people were suffering with diabetes in U. S. in 2010 and declared the disease as the seventh-leading cause of death in the U. S.
About 90% to 95% of deaths in U. S. are caused by Type 2 diabetes, according to sources. The average estimate by three analysts has revealed that the approval of the drug by the FDA, which will be declared by April 15, is expected to generate revenue of $534 million in 2018.